Deliverable 28: Specification of low risk products REBECA ...

More documents

Recommendations

Info

It is proposed, that a safety assessment of a defined taxonomic group should be made based on four pillars (establishing identity, body of knowledge, possible pathogenicity and end use). If the taxonomic group did not raise safety concerns or, if safety concerns existed, but could be defined and excluded the grouping could be granted QPS status. Thereafter, any strain of the micro-organisms given QPS status would be freed for further safety assessments other than satisfying any qualifications specified. The final opinion of the Scientific Committee (including 4 appendices) was adopted on 19 November 2007. Table 1 contains the 4 groups of micro-organisms included in the concept. The committee explains in this document that the group consisting of filamentous fungi could not be recommended QPS status. Further more they explain that all strains belonging to the Bacillus cereus sensu lato group (e.g. Bacillus thuringiensis) should not be given a QPS status either, since it is known that the vast majority of strains within this group are toxin producers and thus can not meet the required qualifications. Table 1. The four groups of micro-organisms which are so far considered in the QPS concept and the number of species proposed for QPS status so far Group of micro-organism Number of species proposed for QPS status so far non-spore forming gram positive bacteria Bacillus spp. yeasts commonly encountered filamentous fungi 48 species 13 species 11 species None The Scientific Committee writes as follows in their opinion of 19 November 2007: “The Scientific Committee is of the opinion that the use of strains from the B. cereus group should be avoided whenever there is a possibility of human exposure whether intended or incidental. The B. cereus group is therefore excluded from consideration for QPS status. There is an artificial distinction held between B. cereus and B. thuringiensis (used for plant protection) which has little scientific basis. The plasmid encoding the insecticidal enterotoxin, which provides the phenotypic distinction for B. thuringiensis, is readily lost, particularly when grown at 37 ºC, leaving an organism indistinguishable from B. cereus. Consequently it is likely that B. thuringiensis has been the causative organism of some instances of food poisoning but identified as B. cereus because clinical investigations would have failed to recognise the distinguishing features characteristic of B. thuringiensis. However, the Scientific Committee recognises that B. thuringiensis has value to the industry as a means of biological pest control and that its widespread use for this purpose may not lead to significant human exposure.” 7
Bacteria directly consumed by humans only qualify for QPS status, if they are free of acquired resistance to antibiotics of importance in clinical and veterinary medicine. Furthermore, all bacteria capable of toxin production should be demonstrated to be free of any toxigenic potential. It is important to stress that QPS does not carry any legal status. Since neither B. thuringiensis nor any of the filamentous fungi are included on the list of species proposed for QPS status, the QPS in its present form does not offer a generic approach to the safety assessment of most micro-organisms used as biological control agents. Never the less, the EFSA Scientific Committee considers that it may be possible to devise robust use qualifications which would allow a QPS approach for further groups of micro-organisms relevant for biological control in the future. The system is developed in order to provide a generic assessment system for use within EFSA that can be applied to all requests for the safety assessment of micro-organisms deliberately introduced into the food chain or used as producer strains for food/feed additives. This implies, that when industry applies for Annex I inclusion of micro-organisms belonging to microbial taxonomic units, which are now included in the list of organisms for which a QPS status is proposed (e.g. Bacillus subtilis and B. pumilus) with the intention to market these in plant protection products, the industry can in their dossier argue that the species are given QPS status, and that the risk for consumer health (due to exposure from residues on crops) is likely to be low when these strains are applied as plant protection products. This information can be used as a waiver for residue data for micro-organisms given QPS status. The list of taxonomic units for which QPS status has been proposed can be found in Annex 1. The applicability of the QPS approach for broad use of micro-organisms as plant protection products needs to be discussed further. USA: Minimal Risk Pesticides (25b list) In the USA, there is a list of substances that can be used as pesticides without any registration, however, they still need a residue limit, or exemption, for food or feed uses. These substances are called Minimal Risk Pesticides, as described in the US Code of Federal Regulation, 40CFR 152.25(f). The list contains many essential oils 1 . All inerts must be on EPA’s 4A inert list, all ingredients must be identified on the label, and the label may not contain false or misleading claims. This regulation was developed by an EPA workgroup in 1994 and revised in accordance with public comments for a final Federal Register publication in 1996. The EPA has experienced a problem since it has been difficult identifying exactly which chemical substances are included under the names listed. Currently, CAS numbers are used to describe the substances on the EPA inert substance classification lists. 1 Currently, the list includes the following substances: castor oil, cedar oil, cinnamon and cinnamon oil, citric acid, citronella and citronella oil, cloves and clove oil, corn gluten meal, corn oil, cottonseed oil, dried blood, eugenol, garlic and garlic oil, geraniol, gernanium oil, lauryl sulfate, lemongrass oil, linseed oil, malic acid, mint and mint oil, peppermint and peppermint oil, 2-phenethyl propionate (2- phenylethyl propionate), potassium sorbate, putrescent whole egg solids, rosemary and rosemary oil, sesame (includes ground sesame, plant) and sesame oil, sodium chloride (common salt), sodium lauryl sulfate, soybean oil, thyme and thyme oil, white pepper and zinc metal strips. 8
Page 1 and 2: Deliverable 28: Specification of lo
Page 3 and 4: Table of contents Introduction.....
Page 5 and 6: Further more the substances which a
Page 7: Regulator’s experiences in defini
Page 11 and 12: Annex I. List of taxonomic units pr
Page 13 and 14: Annex 2 Developing a risk indicator
Page 15 and 16: cannot afford the high costs for a
Page 17 and 18: esulting from microbial pest contro
Page 19 and 20: ERBIC Risk Indicator To our knowled
Page 21 and 22: The multiplication of non-target ri
Page 23 and 24: For a given chemical pesticide, the
Page 25 and 26: Indirect Effects. Indirect effects
Page 27 and 28: Table 7 Risk scores and calculated
Page 29 and 30: These results demonstrate that the
Page 31 and 32: Jaronski ST, Goettel MS & Lomer CJ
Page 33 and 34: Pest Management Regulatory Agency (

Deliverable 28: Specification of low risk products REBECA ...

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?